Ethical Medicines Industry Group (EMIG) NI Meeting
The EMIG Northern Ireland meeting took place on 20th September, with speakers from DHSC, HDA and NPA providing some useful guidance:
- The current regulatory position in NI will continue to operate ‘indefinitely’ until a new position is negotiated between EU/UK. At present, this still requires serialisation to be on NI packs.
- The July UK Command Paper proposed that medicines be removed from the Northern Ireland protocol. This is the position currently being negotiated between EU/UK but this may be subject to change as negotiations develop. The overall aim is to avoid having different GB and NI packs/SKUs.
- The EU has extended the decommissioning grace period which was due to end from Jan-2022. This means that serialised packs coming to GB from EU will not need to be decommissioned. It also means that imported packs stored in GB and destined for NI do not need to go via a separate route of supply.
- MHRA guidance is being updated over the next few weeks to provide further clarification.
- DHSC will aim to give as much notice as possible for any future changes to take effect – they are aware that packaging can take as much as a year to change and will consider this in their timelines.
- Companies who now feel confident to revoke their decision to withdraw supply from NI should update the DaSH Portal to ensure DoH is aware there will not be a termination of supply.